Report: Calif. Stem Cell Agency Needs Overhaul

LOS ANGELES - California has transformed into a major player in stem cell research, but the taxpayer-funded institute responsible has "significant deficiencies" in how research dollars are distributed, experts said Thursday.

A report by the Institute of Medicine found too many members on the board of the California Institute for Regenerative Medicine represented schools that won funding and recommended a restructuring to avoid the appearance of conflict of interest.

California voters in 2004 approved Proposition 71, a state ballot initiative that created CIRM, at a time when there were federal restrictions on human embryonic stem cell research and such work was opposed by some on religious and moral grounds because embryos have to be destroyed to harvest the cells.

The agency was given broad power to distribute $3 billion in bond proceeds to promising research. So far, it has distributed more than $1 billion to some five dozen universities that went mostly toward investments in new buildings and basic research.

The team of 13 experts that reviewed the stem-cell agency’s operations did not judge the merits of individual studies because that was outside the scope of the report and it would have been too time-consuming and costly. But they raised serious questions about how grants were allotted.

The approval process "has some significant deficiencies which need to be improved upon in order to improve CIRM’s credibility and transparency," said Harold Shapiro, an emeritus professor at Princeton University who chaired the report.

In a few short years, CIRM got off the ground and funneled research money with an eye toward stem cell therapies, turning the state into "an international hub of research and development in stem cell biology," the report said.

While the panel did not find any specific cases of conflict, it noted that the potential exists because of how the board is made up.

CIRM is composed of 29 members, mostly from academia. They have the dual role of providing oversight and day-to-day management. While the structure may have worked when CIRM was first launched and shielded it from political meddling, change is needed going forward, experts said.

"They’re not broken but they’re bent," said Sharon Terry, president of the nonprofit Genetic Alliance who was part of the panel. "They need some correction."

Among the recommendations: The board should remain at arm’s length from the management team, focus on providing better oversight and should not decide what projects to fund. It also needs to be more diverse and include more representatives from industry and members with no stake in the grant-awarding process. Experts also favored the creation of an outside scientific group to give advice and expertise.

Some of the suggested changes would require legislative approval, but the panel felt they were needed to erase concerns about possible conflicts of interest.

In a statement, CIRM board chairman Jonathan Thomas said the agency has not had a chance to digest the report. Once board members talk it over with the panel next week, they will decide "on how best to proceed so that we can respond in as thoughtful a manner to the recommendations" as the panel did, Thomas said.

The latest report echoed several others in the past by other groups, which also called for a new governance structure.

"CIRM has not responded in a meaningful way to many previous public interest suggestions or to independent reviews," Marcy Darnovsky of the Center for Genetics and Society said in a statement. "We hope the agency will not continue that pattern."

Since cutting the first check in 2006, CIRM now finds itself at a crossroads. The federal research limits that existed when it was created have been relaxed and it recently shifted focus from basic research to funding projects that can swiftly begin human trials. Experts felt this goal was unrealistic and urged the agency to have a more balanced approach.

At its current funding pace, CIRM is expected to earmark the last grants around 2017, but since most are multi-year awards, it will stay in business until around 2021. It’s currently deciding its future for when the money runs out.

The $700,000 report was sponsored by CIRM - a customary practice for organizations seeking a review. The Institute of Medicine said sponsors have no influence on the fact-gathering process and are barred from reviewing drafts or weighing in on the report before publication.

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